Physical Therapy TechniquesNCT02391376
Heat Transfer by Three Types of Packs and Its Implication on the Flexibility of the Lower Back
A study testing moist heat pack; ;, seed pack and gel pack in people with Physical Therapy Techniques, run by Universidad Católica del Maule.
Trial summary
The purpose of this study is to compare the effects generated by the application of three different packs on the flexibility of the lower back of sedentary students. Method: Three sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed pack-SP or gel pack-GP) were applied on the lower… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Therapy Techniques
- What is being tested?
- moist heat pack; ;, seed pack and gel pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sedentary subjects (physical activity performed less than 3 times-week)
Who cannot join
- recent scars or wounds in the lower back region,
- history of peripheral vascular diseases,
- impaired sensitivity,
- body mass index above 25 kg/m2,
- fat index above 14% according to Faulkner's formula.
About this study
Official title: Heat Transfer by Three Types of Packs and Its Implication on the Flexibility of the Lower Back: a Randomized, Controlled Trial
The purpose of this study is to compare the effects generated by the application of three different packs on the flexibility of the lower back of sedentary students. Method: Three sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed pack-SP or gel pack-GP) were applied on the lower back. Pack and lower back temperatures and erythema were registered every 5 minutes. Schober test was performed before first session and after the third session.
Read the detailed description
A different type of hot pack was applied in the lower back of each subject: moist heat pack (MHP) , seed pack (SP) or gel pack (GP) as directed by each manufacturer and in accordance with clinical practice for 15 minutes for 3 consecutive days. On day one, prior to the application of the pack, the initial evaluation of flexibility of the lumbar spine of each subject was recorded using Schober test. On day 3, after the application of each pack, the final evaluation of the flexibility of the lower back was performed using the same test. During the sessions, the temperature of the corporal area, the temperature of the pack and the pigmentation change of the corporal area were assessed every 5 minutes through a photographic record.The method used to assess the flexibility was the Schober Test. In order to perform the evaluation, the patient was placed in standing position with its bare feet slightly apart; two points were marked on the skin, one above the spinous apophysis S1 and another point, 10 cm above that mark. The patient performed a maximal trunk flexion without flexing the knees and the increase of the distance between the two marks was recorded. After this evaluation, the packs were applied on the lower back, wrapped in two layers of towels in order to avoid skin injuries by the heat. The temperature of the lower back and of each type of pack was recorded at minutes 0 (baseline measurement), 5, 10 and 15. Temperature was measured through a digital pyrometer at a set distance of 50 cm and it was held perpendicular to patient skin and the pack. The photographic record of the lower back of each subject, before and after each session of superficial thermotherapy, was recorded using a digital camera . The camera was placed perpendicular to the lower back, at a distance of 50 cm. The brightness of the photograph was taken into account so as not to affect the later analysis of the erythema. The erythema analysis of the lower back was performed with the freeware Picture Color Analyzer (Shizuoka, Japan; http://www.isao.com). The software measures the red color intensity of each pixel (attributing a value between 1 and 255) within the chosen area. The average red color value obtained in arbitrary units is the result of the following formula: Average red color = total red color value / (255 X number of pixels in the area).
- Conditions
- Physical Therapy Techniques
- Being tested
- moist heat pack; ;, seed pack, gel pack
- Keywords
- superficial heat, hot pack, thermotherapy, physiotherapy, Schober Test
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moist heat pack; ;Other
Three sessions of 15 minutes of superficial heat through a moist heat pack-MHP applied on the lower back.
seed packOther
Three sessions of 15 minutes of superficial heat through a seed pack-SP applied on the lower back.
gel packOther
Three sessions of 15 minutes of superficial heat through a gel pack-GP applied on the lower back.
| Study group | Role | What they receive |
|---|---|---|
| moist heat pack group | Experimental | Three sessions of 15 minutes of superficial heat through a moist heat pack on the lower back of healthy subjects Receives: Other: moist heat pack; ; |
| seed pack group | Experimental | Three sessions of 15 minutes of superficial heat through a seed pack on the lower back of healthy subjects Receives: Other: seed pack |
| gel pack group | Experimental | Three sessions of 15 minutes of superficial heat through a gel pack on the lower back of healthy subjects Receives: Other: gel pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of lower back flexibility (Schober test)
Schober test
Measured: Before first session (day 1) and after the third session (day 3-final day).
Secondary outcomes (2)
Change of pack and lower back temperatures
Measured: every 5 minutes during each one of the three 15 minutes sessions
Change of lower back erythema
Measured: every 5 minutes during each one of the three 15 minutes sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Therapy TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Nasri Marzuca Nassr, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391376
- Sponsor's protocol ID
- TUCM/1261/B326e/2013
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Transfer by Three Types of Packs and Its Implication on the Flexibility of the Lower Back: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02391376
- Acronym / sponsor ID
- TUCM/1261/B326e/2013
- Conditions
- Physical Therapy Techniques
- Keywords
- superficial heat, hot pack, thermotherapy, physiotherapy, Schober Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effects generated by the application of three different packs on the flexibility of the lower back of sedentary students. Method: Three sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed pack-SP or gel pack-GP) were applied on the lower back. Pack and lower back temperatures and erythema were registered every 5 minutes. Schober test was performed before first session and after the third session.
Detailed description
A different type of hot pack was applied in the lower back of each subject: moist heat pack (MHP) , seed pack (SP) or gel pack (GP) as directed by each manufacturer and in accordance with clinical practice for 15 minutes for 3 consecutive days. On day one, prior to the application of the pack, the initial evaluation of flexibility of the lumbar spine of each subject was recorded using Schober test. On day 3, after the application of each pack, the final evaluation of the flexibility of the lower back was performed using the same test. During the sessions, the temperature of the corporal area, the temperature of the pack and the pigmentation change of the corporal area were assessed every 5 minutes through a photographic record.The method used to assess the flexibility was the Schober Test. In order to perform the evaluation, the patient was placed in standing position with its bare feet slightly apart; two points were marked on the skin, one above the spinous apophysis S1 and another point, 10 cm above that mark. The patient performed a maximal trunk flexion without flexing the knees and the increase of the distance between the two marks was recorded. After this evaluation, the packs were applied on the lower back, wrapped in two layers of towels in order to avoid skin injuries by the heat. The temperature of the lower back and of each type of pack was recorded at minutes 0 (baseline measurement), 5, 10 and 15. Temperature was measured through a digital pyrometer at a set distance of 50 cm and it was held perpendicular to patient skin and the pack. The photographic record of the lower back of each subject, before and after each session of superficial thermotherapy, was recorded using a digital camera . The camera was placed perpendicular to the lower back, at a distance of 50 cm. The brightness of the photograph was taken into account so as not to affect the later analysis of the erythema. The erythema analysis of the lower back was performed with the freeware Picture Color Analyzer (Shizuoka, Japan; http://www.isao.com). The software measures the red color intensity of each pixel (attributing a value between 1 and 255) within the chosen area. The average red color value obtained in arbitrary units is the result of the following formula: Average red color = total red color value / (255 X number of pixels in the area).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| moist heat pack group | Experimental | Other: moist heat pack; ;Three sessions of 15 minutes of superficial heat through a moist heat pack on the lower back of healthy subjects |
| seed pack group | Experimental | Other: seed packThree sessions of 15 minutes of superficial heat through a seed pack on the lower back of healthy subjects |
| gel pack group | Experimental | Other: gel packThree sessions of 15 minutes of superficial heat through a gel pack on the lower back of healthy subjects |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- sedentary subjects (physical activity performed less than 3 times-week)
Key exclusion criteria (5 listed)
- recent scars or wounds in the lower back region,
- history of peripheral vascular diseases,
- impaired sensitivity,
- body mass index above 25 kg/m2,
- fat index above 14% according to Faulkner's formula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moist heat pack; ;Three sessions of 15 minutes of superficial heat through a moist heat pack-MHP applied on the lower back. | Other | moist heat pack group |
| seed packThree sessions of 15 minutes of superficial heat through a seed pack-SP applied on the lower back. | Other | seed pack group |
| gel packThree sessions of 15 minutes of superficial heat through a gel pack-GP applied on the lower back. | Other | gel pack group |
Primary outcome
Change of lower back flexibility (Schober test)
Time frame: Before first session (day 1) and after the third session (day 3-final day).
Schober test
2 secondary outcomes
Change of pack and lower back temperatures
Time frame: every 5 minutes during each one of the three 15 minutes sessions
Change of lower back erythema
Time frame: every 5 minutes during each one of the three 15 minutes sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing moist heat pack; ;, seed pack and gel pack in people with Physical Therapy Techniques, run by Universidad Católica del Maule.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lower back flexibility (Schober test) (time frame: Before first session (day 1) and after the third session (day 3-final day).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.